OPINION: What FDA Approval of Pfizer Vaccine Means

Oct 7, 2021
2:26 PM

Boxes containing the Pfizer-BioNTech COVID-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Portage, Mich., Sunday, Dec. 13, 2020. (AP Photo/Morry Gash)

In late August the FDA approved Pfizer’s COVID vaccine. What that means is that the vaccine is effective enough with minimal side effects to be administered nationwide. The FDA reaches this conclusion by looking at all the data collected since the vaccine has been available to medical professionals and the public. 

Approval by the FDA is significant, as the Food and Drug Administration is the premier federal agency “responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.” Basically, if it goes into a human body, the FDA makes sure that it is safe and effective enough for public distribution.

No vaccine will fully prevent someone from getting an illness 100 percent of the time. A vaccine does, however, give you a significant amount of protection from contracting the illness it targets. It also will significantly lower the effects of the illness and the risk of death should you contract the disease. An FDA-approved COVID vaccine is a person’s best defense against the current virus rampaging across the globe. As with any medicine, treatment or cure, it may have some negative side effects, though at such a low level of severity -a sore arm at the injection site, for example- that it is considered safe for most if not all people to take. 

FDA approval gives the green light to vaccination mandates. Though mandates are controversial, approval of the Pfizer vaccine will make it likely that many organizations, public and private, will begin requiring their members, and even patrons, be vaccinated. In fact, the U.S. armed services announced that all military personnel must have at least the first dose by September 27. Far from an infringement on personal rights, it is the right of each and every business to determine, within the law, who they may or may not employ or serve. No shirt. No shoes. No vaccine. No service or employment.

Entire families and communities have decided not to vaccinate, creating a perfect storm for the spread of the disease if even only one member becomes infected. Similarly, some small businesses have made the same decision with catastrophic results. Imagine an employer or employee contracting COVID and recovering while one or more of her or her coworkers does not.

Sadly, some community level healthcare workers, police officers and others are refusing to be vaccinated as well, people whom many look to as role models and authority figures, deciding that the mandate is too great an infringement on personal rights. The decision to put politics and belief over safely is indeed problematic.  

The reality is that rights are not absolute. They are regulated by the social contract that we observe in our communities and the laws enacted and enforced to maintain it. A person can be arrested for yelling “Fire!” in a crowded theater due to the potential risk of panicking people trying to flee en masse from a confined space. Does that infringe on one’s freedom of speech? In absolute terms, yes. But within the context of the social contract and the laws of the land, no. With rights come responsibilities to the community, and often the right of an individual is subordinated to their safety and that of the larger group. 

As a physician I regulary interact with the medical insurance industry. Current rumblings are that, though insurance companies cannot mandate a person take the vaccine, they can decide whether or not to pay for treatment when an unvaccinated person catches COVID. Food for thought. Lawsuit-happy anti-vaxxers should also take note of a recent court decision against those decrying the vaccine. It stated that a healthcare provider, the Methodist Health System in this case, can legally mandate all their employees to be vaccinated. So legal precedence has already landed on the side of the pro-vaccine businesses. 

The tragedy is that the most affected states right now -Alabama, Arkansas, Georgia, Idaho, Louisiana, Mississippi, North Dakota, Tennessee, West Virginia and Wyoming– are also the least vaccinated, mainly due to their political leanings.

Some anti-vaxxers rely on half-baked theories to support their decisions, such as the widespread concern that a tracking device is being injected into the vaccinated by the nefarious leader of a new and shadowy world order. Such logic would be more convincing had the late Steve Jobs not convinced a billion people to buy cell phones that track their every move.

Another often heard argument against vaccination is the technology being used in the vaccine itself, particularly the mRNA vaccine method and its supposed ability to change one’s DNA. But the mRNA method is not new. It was developed in the 1990s for use against other diseases. It holds great promise in combating many illnesses and will undoubtedly help extend our lifespans over the coming decades. It is so effective that we may soon see it being used as a vaccine against illnesses such as cancer or diabetes.

The vaccine booster is also being hotly debated, or should I say ignorantly opposed. One camp argues that boosters are not needed because COVID-19 vaccines “continue to be effective against severe disease, including that caused by the delta variant,” as described in a The Lancet last month. The authors, a group of 18 doctors and scholars, also argue that “the current vaccine supply could save more lives if used in previously unvaccinated populations.” In other words, vaccinate as many people around the world as possible to save the most lives first, before making the booster available to those who have already received their initial shots. 

Another side argues that a booster is really not needed, based primarily on a study published in The New England Journal of Medicine in September, in which the authors, another group of 11 doctors and scholars, write:

“In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least 5 months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine.”

The problem here is that neither study is fully right or wrong. Studies like these are quasi-scientific opinions based on the interpretation of data and not a scientific consensus reached by unbiased parties. These kinds of studies are often contaminated by variables such as the lack of confirmatory data and, at times, investigator bias. When data like this are presented in the media as fact, it is consumed by millions of readers as such, when in reality it hasn’t been fully validated.

Add to this the confusing battle between the CDC and its own director, Rochelle Walensky, who recently overruled the organization’s own findings that a third vaccine is not needed. This is confusing for both healthcare providers and the public, casting doubt on any findings coming from the organizations best suited to guide the public in matters of health and safety. 

Admittedly, vaccine history is full of successes and failures, but the overall trend is positive. Vaccines are not full-proof. They are not a panacea. However, they are far and away the best defense against the current pandemic. Just ask your doctor who, by the way, was probably vaccinated quite some time ago during the first round of available vaccines in December 2020. The data used by the FDA came predominantly from these white-coated guinea pigs, myself including, plus my staff and my family. Once again, the lead will be taken by those children of nurses or doctors to provide data concerning that specific age group and the necessity and efficacy of the booster now being debated.

For the first time in decades the lifespan of Americans has dropped -a major data point. With only three percent of the world’s population and 25 percent of COVID deaths, the United States may finally have a weapon to turn the tide in this war, but only if our citizens choose to use it. Many other countries do not have the same luxury. We should become an example for the rest of the world instead of the butt of their jokes concerning our botched response.

Feel free to exercise your rights, but please do so with the commensurate responsibility to your fellow citizens. Get tested, Mask up. Social distance, and quarantine if sickened. The full approval by the FDA of the Pfizer is stating categorically that the data is in: the vaccine is safe enough, effective enough, and will help prevent more acute illness should another outbreak occurs.

For many, no approval or amount of information will change their minds. However, for those that are hesitant but not abstinent, please take this approval as a recommendation to move forward and protecting yourself, your family and your community. If you choose not to get vaccinated, please do the right thing and wear a mask, social distance, and quarantine if necessary. Only with unified methodologies can we defeat this.

Remember too that many of the people telling us not to vaccinate or wear masks are themselves protected. That politician or media personality is probably fully vaccinated. 

The FDA’s approval of the Pfizer vaccine has lifted a weight off of many shoulders. The responsibility is now left to each individual. Hesitancy will hopefully transition into action. We now have the information many were standing by for. So go get the stick! If you have already done so, get your booster as well once it becomes available. It is simply the right and safe thing to do.


Dr. Lauro Amezcua-Patino is the clinical voice of The Only You (Solo Tú), a podcast dedicated to simplifying the complex issues of the mind and mental illness. Originally from Mexico, Dr. Amezcua-Patino has been practicing in the metropolitan Phoenix area for over 30 years. Twitter: @SuSaludMental.